MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM; MESH, SURGICAL

Catalog Number 1010002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hernia (2240); Obstruction/Occlusion (2422)

Event Date 12/09/2015

Event Type  Injury  

Manufacturer Narrative

The internal investigation into strattice lot s11301 included a review of the reported information, review of the device history records and review of the complaint history records.The device was not returned to lifecell for evaluation.Investigation results revealed no remarkable findings with no similar complaints reported against the lot and no related deviations or nonconformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.To date, of the 196 devices released to finished goods for lot s11301, 186 have been distributed.No further actions are required as a nonconformance could not be confirmed.

Event Description

It was reported that a (b)(6) year old male underwent a ventral/umbilical hernia repair on (b)(6) 2013 by dr.(b)(6).The patient was implanted with strattice lot s11301-041.Two years after the surgery, the patient returned to the hospital on or about (b)(6) 2015 and was diagnosed with a partial small bowel obstruction.The patient had a release of partial small bowel obstruction, repair of recurrent ventral/umbilical hernia and removal of old mesh at (b)(6) hospital performed by dr.(b)(6).The patient was implanted with another piece of strattice, lot sp100295-142.After surgery, the patient returned to the hospital on (b)(6) 2016 and was diagnosed with small bowel obstruction.On (b)(6) 2016, the patient had a release of small bowel obstruction, release of internal hernia and excision of strattice mesh a medical west hospital.This record is associated with the first reported lot, s11301-041.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12161051
• MDR Text Key: 265174086
• Report Number: 1000306051-2021-03025
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1010002
• Device Lot Number: S11301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR